The use of vaccines to prevent and eradicate diseases like smallpox and poliomyelitis is
one of the great successes of modern medicine. But recent developments supply grounds for
skepticism about new vaccine initiatives. The corrupting influences are money and
politics.

In the past ten years, vaccines have become very profitable for drug companies. At one
time, the DTP (Diphtheria, Tetanus, Pertussis) vaccine sold for 10 cents per dose, and the
drug manufacturers were dropping out of the market because of low profits and liability
problems.(1) But in 1986, Congress sheltered the drug companies from liability. Those
injured by vaccines can make claims against a special government fund. There is also a lot
more money in the vaccine business. New vaccines are usually patented, and can sell for
hundreds of dollars. Aggressive new vaccine requirements have made the market even more
lucrative.

The vaccine market is also a perfect target for socialistic do-gooders, because
nobody questions a plan to prevent children from getting crippling diseases. Many in
the Clinton administration and elsewhere believe that the federal government should manage
the health care industry, and that all Americans should carry national ID cards which link
them to a national medical database. Portions of this plan were passed by Congress in the
1996 Health Insurance Portability and Accountability Act (also known as Kassebaum-Kennedy)
which mandated a national ID number for tracking personal medical histories. The pilot
project for this Orwellian scheme is the Immunization Registry at the Centers for Disease
Control (CDC).(2) The Clinton administration is currently lobbying to repeal state
privacy laws so that government officials will have unfettered access to private medical
records. The plan is to do this first under the guise of removing obstacles to childhood
immunization, and then to extend the database to other types of medical records later.

United States immunization policy is largely dictated by the CDC. It appoints members
of the Advisory Committee on Immunization Practices (ACIP), which then makes a
schedule of vaccine recommendations and publishes it in the CDC Morbidity and Mortality
Weekly Report. The members are often nominated by the drug companies and have
substantial financial ties to the drug companies. Portions of the ACIP meetings are open
to the public, but portions are also secret. Members are forbidden to publicly discuss
what happens during closed portions of the meetings. The precise scientific, medical, and
political bases for the vaccine recommendations are never revealed.

Thus the drug companies and the CDC have strong incentives to expand immunization
programs. Physicians have a duty to critically examine whether this expansion is good
for the health of their patients. It is not necessarily true that all vaccines are
good for all people.

One of the current ACIP recommendations is that all newborn babies be given the
hepatitis B vaccine within 24 hours of birth. This is not a conservative recommendation.
Such a vaccination might be justified in cases where the mothers test positive for
hepatitis B, but the babies are at extremely low risk otherwise. The biggest risk of
hepatitis B to the babies occurs many years later when they grow up and then as
adolescents become sexually active.(3)

Is the hepatitis B vaccine safe? It is hard to say based on the available evidence.
There is epidemiological evidence that suggests it is quite safe, but there are also
reports that it causes autoimmune and neurological disorders, and there have been no
controlled tests which looked at such effects. The vaccine authorities do not like to do
long-term tests of vaccine side-effects for fear that merely doing a test would provide
ammunition to vaccine skeptics. France recently suspended hepatitis B vaccinations of
schoolchildren because of fears that the vaccine causes multiple sclerosis and other
diseases.(4) In spite of this concern, all American newborns are being vaccinated.

Another ACIP recommendation is the oral polio vaccine. The World Health Organization
has declared polio eradicated from the western hemisphere. The last case of polio "in
the wild" was in Peru in 1991. Yet, the live oral polio vaccine is still given, and
some people still get polio from the vaccine.

Last year, the ACIP recommended the rotavirus vaccine. Rotavirus causes diarrhea in
babies, but is not particularly common, severe, or contagious. The ACIP made the
recommendation without even knowing the price of the vaccine (i.e., what the drug
manufacturer was going to charge), so it is obvious that a cost/benefit analysis of the
vaccine was not done.(5)

The CDC immunization policy is disgraceful from a scientific, medical, or public policy
point of view. It is a scientific disgrace because vaccines only get short-term or
epidemiological tests, and not controlled tests for long-term side effects. We do not
know, for example, whether the radical increase in vaccinations during the last 20 years
has any relation to the observed increase in incidence of asthma over the last 20 years.(6)

The immunization policy is a medical disgrace because physicians have been pressured to
abandon their ethical principles of privacy and informed consent and freedom of choice for
their patients. How many pediatricians tell their patients that they are more likely to
get polio if they choose to get the vaccine? If they did, usage of the oral polio vaccine
would plummet.

The immunization policy is a public policy disgrace because it is a secretive process
conducted by biased and unaccountable parties. Ideally, the ACIP should:

1. Use an open process. All data, meetings, considerations, etc. should be open
to the public, and rationales for all decisions should be documented.
2. Have a more representative membership. While vaccine researchers on the drug
manufacturer payroll might be the most knowledgeable, most of the ACIP decisions concern
public policy rather than biochemistry. Munitions experts develop plans for bombing Iraq,
but they are not the ones who make the final decision of whether or not to bomb.
3. Publish the complete rationale for vaccine recommendations. There is no excuse
for using proprietary and unrefereed company data or confidential political directives to
make public policy.
4. Separate science and medicine from policy analysis in the vaccine
recommendations.
5. Make a scientific analysis of the risks and benefits of particular vaccines.

Now you may think that the arguments for vaccinations are so compelling that all of
this is unnecessary. But consider these arguments for vaccine policies.

1. The vaccine must be mandatory for all Americans in order to make it
cost-effective for the drug manufacturer.
2. A discriminatory policy might be more effective, but it would not be politically
viable. (For example, we could just give the rubella vaccine to girls, since the only
significant risk is to pregnancies in later life. Other diseases affect certain ethnic
groups disproportionately.)
3. The disease is no worse than a mild cold, but a vaccine might have a favorable
cost/benefit analysis if it is based on saving the mother from taking a day off work.
4. The disease has been eradicated from this country, but we continue to vaccinate in
order to set a good example for third world countries.
5. The vaccine is useless now, but it has been a tremendously positive thing in the past
and we like to maintain the tradition.
6. The disease is risky for promiscuous and IV drug-abusing teenagers, but parents will
not reliably predict such behavior so we give the vaccine to everyone at birth.
7. A live virus vaccine is preferred over a safer killed virus vaccine because the live
virus vaccine has the secondary effect of exposing unvaccinated children to the virus.
8. The vaccine is more likely to cause harm than good on an individual basis but might
still be good for society at-large because of the "herd immunity" effect.
9. The HIV vaccine is ineffective, but we need to flag the national vaccine registry
entries of the people who are at risk for HIV so we can monitor other diseases that they
might be spreading.
10. The vaccine is only medically justified for a particular ethnic group that is
susceptible to the disease, but it is better to vaccinate everyone so that the group is
not stigmatized.
11. The risk of getting the disease and dying is 1 in 300,000, and the risk of getting
brain damage from the vaccine is 1 in 100,000. It is better to have three brain-damaged
babies than one dead baby.
12. Vaccines make a very powerful argument for socialized medicine. Even hard-core
libertarians usually admit that it is good to have government-sponsored vaccinations. A
broader and centrally-managed vaccine program that goes unchallenged will set an example
for government management of other medical operations.

All of these arguments are controversial. Most of them have been used to justify
vaccines. Physicians who are being asked to recommend and administer vaccines need to
know whether some of these arguments are part of the CDC's rationale. Unfortunately, we do
not know. And we are unlikely to find out, because the CDC would consider revealing these
reasons to be counterproductive.

Meanwhile, the practicing physician is caught in the middle. He is responsible for
informing the patient of the risks and benefits, but his information from the CDC and the
drug manufacturers is incomplete, at best. He has an ethical responsibility to give his
patients an informed choice, but government authorities will use computer databases to
monitor his compliance with official recommendations and seek to pressure him if his
vaccination rates are low.

The average physician does not have the time and know-how to evaluate all of the
evidence and arguments. The drug companies cannot be trusted because they are sheltered
from liability. Besides, not even the drug companies claim their vaccines are good for
everyone. Physicians need the CDC to fund experiments, collect data, and do analysis. What
it does, though, falls quite a bit short of what is needed.

The vaccine analysis should clearly state the risk model. That is, it should say what
risks are being estimated, what assumptions underlie the measurement of those risks, and
what data contributes to the measurement. Only with such a risk model can someone draw any
conclusions about risk to a particular individual.

The analysis should also separate science and medicine from policy analysis. Policy
analysis, according to standard textbooks(7) and even the ACIP charter, should:

But the ACIP never carries out these steps. Vaccine researchers and government
bureaucrats are setting policies which are more political than scientific, and they are
never required to reveal the bases for their decisions.

The ACIP does state its purpose, but it is not the purpose you might expect. The stated
purpose of the ACIP is to increase the use of vaccines, not to promote health. According
to its charter: "The overall goals of the ACIP are to provide advice which will
assist the Department and the Nation in reducing the incidence of vaccine preventable
diseases and to increase the safe usage of vaccines and related biological products,
including active and passive immunoprophylaxis."(8) Thus nearly all of the
controversial arguments listed above are consistent with the goals of the ACIP.

Finally, there should be a cost/benefit analysis of the vaccine. The vaccine
should be good for society as a whole, in some sense which has clearly stated assumptions
and quantitative conclusions. The costs and benefits may vary from one patient to the
next, so the cost/benefit analysis should also give individuals a way to apply it to their
own situations. As with any other medical procedure, a drug which is favorable to some
people is apt to be unfavorable to others.

Ideally, the drug manufacturers would also supply these analyses and stand behind their
products. But in today's market, the companies only need to do enough studies to get FDA
approval, and publish a list of all the adverse reactions reported in the studies. Most
people would not take the vaccines if they only read the drug company literature. The
companies rely on the CDC and individual physicians to vouch for the vaccines in a way
that the companies themselves will not do.

The CDC is not likely to move to an open and honest vaccine policy any time soon. There
is too much money and politics favoring a dictatorial vaccine policy. The currently high
vaccination rates (90 percent or so) would be very difficult to achieve based on reason
and persuasion alone, and would be impossible if the public realized how weak the case is
for some of the vaccines. The current policies of misinformation and intimidation are much
more effective, and in the eyes of CDC do-gooders, anything which purportedly benefits
children and promotes government medical programs is a good thing.

References/Notes

1. Plotkin SA, Mortimer EA. (eds.) Vaccines, Philadelphia, W. B. Saunders, 1994. This
collection of articles has a wealth of medical information about vaccines.
2. See details at www.cdc.gov/nip/registry.
3. "The effect of routine infant vaccination on acute disease incidence may not be
apparent for 20-30 years because currently most infections occur among young adults."
Morbidity and Mortality Weekly Report, Vol. 44, No. 30, Aug. 4, 1995.
4. "In a sudden reversal of health policy, France has decided to suspend Hepatitis B
vaccinations in secondary schools because of fears that the vaccine causes neurological
disorders." New York Times, Oct. 3, 1998.
5. ACIP meeting minutes, Feb. 1998. Available from CDC.
6. The Economist 1998;344(8044):95(3). It suggested possible correlations between vaccines
and other diseases such as asthma.
7. Patton CV, Sawicki DS. Basic Methods of Policy Analysis, Prentice Hall, 1993.
8. ACIP Policies and Procedures, July 1998. Available from the CDC or from
www.mindspring.com/~schlafly/vaccfaq.htm. Some other supporting evidence on immunization
policy is also there.

Dr. Schlafly is summa cum laude B.S.E. from Princeton, has a PhD in mathematics from
the University of California at Berkeley, and has held teaching positions at the
University of Chicago and the University of California at Santa Cruz . His e-mail is
real@ieee.org. His website is www.mindspring.com/~schlafly/vaccfaq.html.